Identification of reactive Borrelia burgdorferi peptides associated with Lyme disease.
Rafal Tokarz, Cheng Guo, Santiago Sanchez-Vicente...
https://pubmed.ncbi.nlm.nih.gov/39248571/Actively Recruiting
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-08-07
700
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating whether the Lyme disease bacteria, Borrelia burgdorferi, remain alive in patients after antibiotic treatment and whether this persistence causes ongoing symptoms. The study aims to better define diagnostic criteria for Lyme disease and support the development of future treatment trials by following a well-characterized group of patients with post-treatment Lyme disease syndrome PTLDS and various control groups. Participants include those with chronic Lyme disease, Lyme arthritis, multiple sclerosis, previous Lyme infection with full recovery, seropositive individuals without symptoms, and healthy volunteers. Participants undergo physical exams and tests including blood tests, white blood cell collection or blood draw, lumbar puncture, brain MRI, neuropsychological assessments, and sometimes hearing tests and urine collection. Those testing positive for the bacteria are monitored every 3 to 6 months and may receive antibiotic treatment with ceftriaxone, followed by scheduled follow-ups with repeated tests and imaging to evaluate treatment response. Throughout the study, participants are regularly assessed with clinical exams, imaging, laboratory tests, and questionnaires to understand disease progression and immune response. The research team collects data on biological markers, develops new diagnostic tests, and monitors symptoms and treatment outcomes over time. Participants may be reevaluated at intervals of 6 to 12 months, contributing to a detailed database to guide future Lyme disease research and therapies.
CONDITIONS
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
A
Ashley M Thomas
A
Adriana R Marques, M.D.
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility through history, physical examination, and laboratory tests including blood and urine analysis.
1 to 2 visits depending on antibody levels
Duration - Initial assessment period varies
Participants undergo physical exams, blood tests including HLA typing, leukapheresis or blood draws, lumbar puncture, brain MRI, neuropsychological testing, and possibly hearing and urine tests.
Multiple visits as needed for testing
Duration - Up to 12 months or longer as needed
Participants with positive Borrelia burgdorferi tests are followed every 3 to 6 months. Those treated with antibiotics receive follow-up visits at 1 week, 3 months, 6 months, and 12 months with repeated tests and imaging to assess treatment response.
Regular visits at specified intervals during follow-up
Duration - Ongoing at 6 to 12 month intervals
Participants with chronic Lyme disease and related controls may be reevaluated every 6 to 12 months to monitor health status and disease progression.
Periodic visits depending on participant status
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
8
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Rafal Tokarz, Cheng Guo, Santiago Sanchez-Vicente...
https://pubmed.ncbi.nlm.nih.gov/39248571/Adriana R Marques, Xiuli Yang, Alexis A Smith...
https://pubmed.ncbi.nlm.nih.gov/28878005/National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor